MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-19 for GN RESOUND RECEIVER IN THE CANAL HEARING/AID DOME 7MM OPEN EXCELIA ACT M WIND manufactured by Gn Resound.
[106199519]
Veteran reported to er for second time to have dome of hearing aid retrieved from ear canal. Dome easily retrieved without injury or insult.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076583 |
| MDR Report Key | 7446544 |
| Date Received | 2018-04-19 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-01 |
| Date Added to Maude | 2018-04-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GN RESOUND RECEIVER IN THE CANAL HEARING/AID DOME 7MM OPEN |
| Generic Name | HEARING AID AIR CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-04-19 |
| Model Number | EXCELIA ACT M WIND |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN RESOUND |
| Manufacturer Address | 8001 E. BLOOMINGTON FWY BLOOMINGTON MN 55400 US 55400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-19 |